Creo Medical - A sterile, flexible, invasive, endoscopic device - CREO MEDICAL LIMITED

Duns Number:733853373

Device Description: A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submuc A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device.

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More Product Details

Catalog Number

7-RS2-001

Brand Name

Creo Medical

Version/Model Number

7-RS2-001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K171983,K171983

Product Code Details

Product Code

KNS

Product Code Name

Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Device Record Status

Public Device Record Key

17a07c0e-4ef9-4eec-ac46-a1cfb6ed6912

Public Version Date

November 17, 2020

Public Version Number

3

DI Record Publish Date

November 14, 2018

Additional Identifiers

Package DI Number

05060359560049

Quantity per Package

5

Contains DI Package

05060359560025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box

"CREO MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6